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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03641287
Other study ID # RG1001826
Secondary ID 10045NCI-2018-01
Status Terminated
Phase N/A
First received
Last updated
Start date December 5, 2018
Est. completion date September 30, 2022

Study information

Verified date November 2023
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Many individuals with ovarian cancer experience distress, fatigue, weakness, anxiety, and other symptoms that decrease quality of life. Moderate exercise may improve quality of life, decrease distress, and improve biomarkers associated with prognosis in individuals with ovarian cancer. This clinical trial studies how well moderate exercise works in improving distress, quality of life, and biomarkers of angiogenesis and chronic stress in individuals with ovarian, fallopian tube, and primary peritoneal cancer.


Description:

OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (EXERCISE INTERVENTION): Patients meet with exercise physiologist for 1, 60 minute session. Patients then receive individualized exercise prescription with goal of moderate aerobic exercise over 150 minutes per week at home for up to 24 weeks. Patients also receive telephone-based motivational support by exercise physiologist weekly for 24 weeks. ARM II (CONTROL GROUP): Patients maintain habitual levels of physical activity and receive general education material about ovarian cancer and survivorship for 24 weeks. After 24 weeks, patients are offered exercise intervention.


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Study Design


Related Conditions & MeSH terms

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Intervention

Other:
Exercise Counseling
Meet with exercise physiology
Aerobic Exercise
Receive prescription for moderate aerobic exercise
Physiological Support
Receive motivational support via telephone care
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Best Practice
Undergo habitual level of physical activity

Locations

Country Name City State
United States Fred Hutch/University of Washington Cancer Consortium Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Quality of Life Measured Using the RAND 36-item Short Form Health Survey Physical Component Score Will be measured using the RAND 36-item Short Form Health Survey Physical Component Score. Mean change from baseline to 24 weeks between the exercise intervention and control group in the RAND 36-item Short Form Health Survey Physical Component Score.
RAND 36-Item Short Form assesses eight subscales including physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, general health perceptions, and perceived change in health. Possible scores for each subscale range from 0 to 100. The Physical Component Score (PCS) is an aggregate of the eight subscales using a standardized algorithm, with a mean of 50 and standard deviation of 10 in the general US population. Possible scores range from 20 to 60, with higher scores indicating a better quality of life.
Baseline up to 24 weeks
Primary Change in Distress, Measured Using the Perceived Stress Scale Will be measured using the Perceived Stress Scale. Mean change from baseline to 24 weeks between the exercise intervention and control group in the Perceived Stress Scale.
The Perceived Stress Scale is a 10 item questionnaire with a total score range of 0-40. Higher total scores indicate higher distress.
Baseline to 24 weeks
Primary Change in Distress, Measured Using the Hospital Anxiety and Depression Scale - Anxiety Subscale Will be measured using the Hospital Anxiety and Depression Scale - Anxiety subscale. Mean change from baseline to 24 weeks between the exercise intervention and control group in the Hospital Anxiety and Depression Scale - anxiety subscale.
The Hospital Anxiety and Depression Scale includes 2 subscales: anxiety and depression.
The Hospital Anxiety and Depression Scale - anxiety subscale total scores range from 0 to 21; higher scores indicated greater severity of anxiety symptoms.
Baseline to 24 weeks
Primary Change in Distress, Measured Using the Hospital Anxiety and Depression Scale - Depression Subscale Will be measured using the Hospital Anxiety and Depression Scale - Depression sub scale. Mean change from baseline to 24 weeks between the exercise intervention and control group in the Hospital Anxiety and Depression Scale - Depression subscale.
The Hospital Anxiety and Depression Scale includes 2 subscales: anxiety and depression.
The Hospital Anxiety and Depression Scale - Depression subscale total scores range from 0 to 21; higher scores indicated greater severity of depression symptoms.
Baseline to 24 weeks
Primary Change in IL-6 (Biomarker of Angiogenesis) Mean change from baseline to 24 weeks between the exercise intervention and control group in mean levels of IL-6. Baseline to 24 weeks
Primary Change in VEGF (Biomarker of Angiogenesis) Mean change from baseline to 24 weeks between the exercise intervention and control group in mean levels of VEGF. Baseline to 24 weeks
Primary Change in Nocturnal Cortisol (Biomarker of Chronic Stress) Mean change from baseline to 24 weeks between the exercise intervention and control group in mean level of evening salivary cortisol. Baseline to 24 weeks
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